Ocular Hypertension, Open-angle Glaucoma
Conditions
Brief summary
This study will assess angle width in Chinese patients with Open-angle Glaucoma and/or Ocular Hypertension.
Interventions
OTHERNo Treatment
No Treatment was given in this study.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Of Chinese descent * Open-angle Glaucoma or Ocular Hypertension in each eye
Exclusion criteria
* History of a narrow-angle or angle closure glaucoma * Angle abnormalities in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT) | Day 1 | The angle width formed between the eye's cornea and iris in both eyes was measured in microns (µm) using AS OCT, a laser-based, noninvasive, diagnostic system providing high-resolution images of the eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens | Day 1 | The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Shaffer grading where: grade 4=wide open, grade 3=moderately open, grade 2=moderately narrow, grade 1=very narrow or grade 0=closed. The number of eyes in each Shaffer Grade is reported. |
| Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Day 1 | The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Large Step Grading ranging from 1.0 (smallest angle width) to 7.5 (largest angle width) with 0.5 unit intervals where each Large Step unit represented a fixed length of approximately 200 µm. The number of eyes in each Large Step Grade is reported. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients. | 206 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other Miscellaneous Reasons | 5 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized 45 to 65 years | 71 Participants |
| Age, Customized <45 years | 111 Participants |
| Age, Customized >65 years | 24 Participants |
| Sex: Female, Male Female | 91 Participants |
| Sex: Female, Male Male | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 206 |
| serious Total, serious adverse events | 0 / 206 |
Outcome results
Primary
Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT)
The angle width formed between the eye's cornea and iris in both eyes was measured in microns (µm) using AS OCT, a laser-based, noninvasive, diagnostic system providing high-resolution images of the eye.
Time frame: Day 1
Population: Participants from the Modified Intent-to-treat (mITT) population, all enrolled patients with both gonioscopy and AS OCT measurements, with evaluable data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT) | 638.8 µm | Standard Deviation 272.67 |
Secondary
Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens
The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Shaffer grading where: grade 4=wide open, grade 3=moderately open, grade 2=moderately narrow, grade 1=very narrow or grade 0=closed. The number of eyes in each Shaffer Grade is reported.
Time frame: Day 1
Population: Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| All Participants | Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens | Grade 1 | 1 eye | — |
| All Participants | Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens | Grade 2 | 1 eye | — |
| All Participants | Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens | Grade 3 | 34 eye | 334.86 |
| All Participants | Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens | Grade 4 | 369 eye | 262.33 |
Secondary
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Large Step Grading ranging from 1.0 (smallest angle width) to 7.5 (largest angle width) with 0.5 unit intervals where each Large Step unit represented a fixed length of approximately 200 µm. The number of eyes in each Large Step Grade is reported.
Time frame: Day 1
Population: Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 1.0 | 0 eye | 126.92 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 1.5 | 4 eye | 203.66 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 2.0 | 36 eye | 206.72 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 2.5 | 32 eye | 212.36 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 3.0 | 78 eye | 191.87 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 3.5 | 24 eye | 234.94 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 4.0 | 69 eye | 290.2 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 4.5 | 23 eye | 208.44 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 5.0 | 34 eye | 119.57 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 5.5 | 9 eye | 221.46 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 6.0 | 33 eye | 184.16 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 6.5 | 28 eye | 294.97 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 7.0 | 28 eye | 158.44 |
| All Participants | Number of Study Eyes in Each Step Grade Using Gonioscopic Lens | Step Grade 7.5 | 7 eye | — |